Browse Drug Recalls

1,091 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,091 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,091 FDA drug recalls in CA.

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DateProductReasonClassFirm
May 14, 2026 Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Asclemed USA Inc.
Apr 27, 2026 Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle... Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll... Class II Oasis Medical, Inc.
Apr 1, 2026 EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... Lack of Assurance of Sterility Class II International Medication Systems Ltd.
Mar 25, 2026 Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... Lack of Assurance of Sterility Class II Preferred Pharmaceuticals, Inc.
Mar 3, 2026 STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and t... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (1... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), S... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Dec 27, 2025 TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per b... Incorrect Product Formulation: product did not contain insulin as listed in the label. Class II Central Admixture Pharmacy Services, Inc (CAPS)...
Nov 26, 2025 Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... Presence of Foreign Tablets/Capsules Class II Golden State Medical Supply Inc.
Nov 17, 2025 Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Phar... Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... Class II Preferred Pharmaceuticals, Inc.
Oct 20, 2025 SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Wo... Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. Class I ANTHONY TRINH, 123Herbals LLC
Oct 20, 2025 NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Oct 10, 2025 Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... CGMP Deviations Class II CA BOTANA International, Inc.
Sep 12, 2025 Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Sep 12, 2025 edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... Class II Private Label Skin Care Inc.
Aug 28, 2025 Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count... Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil Class I Green Lumber Holdings, LLC
Jul 1, 2025 PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... Class II Central Admixture Pharmacy Services, Inc (CAPS)...
Apr 28, 2025 temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by:... CGMP Deviations Class II Siddha Flower Essences, LLC.
Apr 18, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... cGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Apr 15, 2025 Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), ... Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are ... Class II Nubratori, Inc
Mar 31, 2025 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... Presence of Particulate Matter Class II B. Braun Medical Inc
Mar 7, 2025 Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister c... Defective Container: blister packs not properly sealed resulting in tablets being loose in the ca... Class II ASEGUA THERAPEUTICS LLC
Mar 5, 2025 PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Feb 27, 2025 Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
Feb 27, 2025 Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
Dec 16, 2024 FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... Class I SHOPPERS- PLAZA

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.